Urinary Catheter Protective Tips Having A Fluid Reservoir

ABSTRACT

A catheter assembly includes a catheter at least partially positioned within a sleeve. The catheter has a coating, which produces a low-friction surface on the catheter when treated with an activating fluid. A protective tip is connected to the sleeve and has proximal and distal internal seals, with the proximal seal at the proximal end of the tip or between proximal and distal ends of the protective tip. A cap of the assembly has a projection, which is removably received within the protective tip for sealing engagement with the proximal and distal seals to define a fluid reservoir within the protective tip. An activating fluid is contained within the fluid reservoir. The projection may be partially hollow to receive a portion of the catheter. The sleeve may be relatively narrow or at least have a narrowed portion for better distribution of activating fluid to the surface of the catheter.

RELATED APPLICATION

This application claims the benefit of and priority of U.S. ProvisionalPatent Application Ser. No. 61/911,535, filed Dec. 4, 2013, the contentsof which are incorporated by reference herein.

DESCRIPTION

1. Technical Field

The present disclosure generally relates to urinary catheters. Moreparticularly, the present disclosure relates to urinary cathetersprovided with a protective tip having a fluid reservoir.

2. Background

Intermittent catheterization is a good option for many users who sufferfrom various abnormalities and pathologies of the urinary system and itsnerve supply. Such catheters are typically provided as single use,individually packaged items and may include a gel-lubricant orhydrophilic coating as a lubricant for reducing friction duringinsertion into the urethra.

Regarding gel-coated catheters, a user applies a gel-lubricant, such asa water-based gel-lubricant, to the surface of the catheter, whichreduces friction for ease of insertion into the urethra. In someinstances, the gel-lubricant is supplied with the packaged catheter, inwhich case the gel-lubricant may be applied to the catheter surface justbefore or during the packaging operation or as the catheter is beinginserted by the user.

When a hydrophilic material is used as a lubricant, a thin coating ofhydrophilic material is applied to the outer surface of the catheter,and may subsequently be radiation- or heat-cured. When this coating isactivated by swelling in contact with a hydrating liquid or wettingagent such as water, it provides a hydrated surface having an extremelylow coefficient of friction. One form of this product provides asterile, individually packaged, single-use catheter in a dry state orcondition. The user opens the package, pours water into the package,waits 30 seconds, and then removes the catheter from the package, whichis now ready for insertion. Other embodiments provide the amount ofwetting agent necessary for immersion of the catheter in a separatecompartment of the package. In such embodiments, the user must open theseparate compartment of the package to allow the wetting agent to enterthe catheter-containing chamber for direct contact with the hydrophiliccoated surface. The catheter is then removed from the package andinserted into the urethra. In yet another embodiment, the ready-to-usecatheter is provided in a package that already contains enough loosewetting agent to cause it to be immersed. In such an embodiment, theuser simply opens the package and removes the catheter therefrom, andthen inserts the catheter into the urethra, without the need to add thewetting agent.

A disadvantage of the hydrophilic coated catheters described above isthat the immersion liquid has a tendency to spill from the package asthe user handles the catheter and tries to remove it for subsequentinsertion.

SUMMARY

There are several aspects of the present subject matter which may beembodied separately or together in the devices and systems described andclaimed below. These aspects may be employed alone or in combinationwith other aspects of the subject matter described herein, and thedescription of these aspects together is not intended to preclude theuse of these aspects separately or the claiming of such aspectsseparately or in different combinations as set forth in the claimsappended hereto.

In one aspect, a catheter assembly includes a sleeve, with a catheter atleast partially positioned within the sleeve. The catheter has a coatingon at least a part of its length, which produces a low-friction surfaceon the catheter when treated with an activating substance. A protectivetip is connected to the sleeve and has proximal and distal internalseals, with the proximal seal positioned at the proximal end of theprotective tip or between proximal and distal ends of the protectivetip. A cap has a projection removably received within the protective tipfor sealing engagement with the proximal and distal seals to define afluid reservoir within the protective tip. An activating fluid iscontained within the fluid reservoir.

In another aspect, a catheter assembly includes a sleeve, with acatheter at least partially positioned within the sleeve. The catheterhas a coating on at least a part of its length, which produces alow-friction surface on the catheter when treated with an activatingsubstance. A protective tip is connected to the sleeve and defines afluid reservoir, with an activating fluid contained therein. A cap has aprojection removably received within the protective tip. The catheterassembly also includes at least one fluid-tight film seal, with the filmseal being positioned outside of the protective tip and extendingbetween an outer surface of the protective tip and an outer surface ofthe cap or projection, within the fluid reservoir and extending betweenan internal surface of the protective tip and an outer surface of theprojection, or within the sleeve and connected to a distal end of theprotective tip.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a proximal portion of an embodimentof a catheter assembly according to an aspect of the present disclosure;

FIG. 2 is a side elevational view of the proximal portion of thecatheter assembly of FIG. 1;

FIG. 3 is a side elevational view of the proximal portion of thecatheter assembly of FIG. 1, with a cap of the catheter assemblypartially removed from a protective tip of the catheter assembly;

FIG. 4 is a side elevational view of the proximal portion of thecatheter assembly of FIG. 1, with a cap of the catheter assembly fullyremoved from a protective tip of the catheter assembly;

FIG. 5 is a side elevational view of the catheter assembly of FIG. 1;

FIG. 6 is a cross-sectional view of a proximal portion of anotherembodiment of a catheter assembly according to an aspect of the presentdisclosure;

FIG. 7 is a cross-sectional view of a proximal portion of yet anotherembodiment of a catheter assembly according to an aspect of the presentdisclosure;

FIG. 8 is a cross-sectional view of a proximal portion of anotherembodiment of a catheter assembly according to an aspect of the presentdisclosure;

FIG. 9 is a cross-sectional view of a proximal portion of yet anotherembodiment of a catheter assembly according to an aspect of the presentdisclosure;

FIG. 10 is a side elevational view of a catheter assembly incorporatingan alternative sleeve according to an aspect of the present disclosure;and

FIG. 11 is a side elevational view of a catheter assembly incorporatinganother alternative sleeve according to an aspect of the presentdisclosure.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing adescription of the present subject matter, and it is understood that thesubject matter may be embodied in various other forms and combinationsnot shown in detail. Therefore, specific embodiments and featuresdisclosed herein are not to be interpreted as limiting the subjectmatter as defined in the accompanying claims.

FIGS. 1 and 2 illustrate an embodiment of a catheter assembly 10, suchas a urinary catheter assembly. The catheter assembly 10 may bevariously configured without departing from the scope of the presentdisclosure, but in one embodiment, the catheter assembly 10 includes acatheter 12 (such as a urinary catheter) at least partially positionedwithin a sleeve 14, which may be defined by a flexible polymericmaterial (such as, but not limited to, polyurethane) wrapped about thecatheter 12. A protective tip 16 is secured or connected to a proximalend 18 of the sleeve 14, with an opposite or distal end 20 of the sleeve14 (FIG. 5) being sealed or otherwise closed to define a sealedcontainer for the catheter 16.

The protective tip 16 extends between a distal end 22 and a proximal end24. The protective tip 16 is sealingly connected or secured to thesleeve 14 at or adjacent to the distal end 22 of the protective tip 16.The proximal end 24 of the protective tip 16 may include an aperture oropening 26 that may be moved between a closed configuration (in whichthe catheter 12 is fully positioned within the sleeve 14 and protectivetip 16 and there is no other object positioned within the opening 26)and an open configuration (in which the catheter 12 or any other objectis partially positioned within or extending through the opening 26, witha portion of the object positioned within the protective tip 16 andanother portion positioned outside of the protective tip 16). In oneembodiment, the opening 26 is provided as a slit opening with one ormore slits or cuts defining a plurality of deformable petals that may bemoved to define the aforementioned open and closed configurations. Inother embodiments, the opening may be differently configured, providedthat it is configured to allow passage of the catheter therethrough. Aswill be described in greater detail below, the protective tip 16 mayinclude an internal proximal seal or sealing surface or sealing member28 and an internal distal seal or sealing surface or sealing member 30(FIG. 1), with the seals 28 and 30 being spaced from each other and atleast the proximal seal 28 positioned between the proximal and distalends 24 and 22 of the protective tip 16.

The catheter assembly 10 may further include a cap 32 configured to beremovably connected to the protective tip 16. As shown in FIG. 1, thecap 32 may be connected to a proximal portion of the protective tip 16so as to form a substantially fluid- or water-tight seal, which enclosesthe opening 26 at the proximal end 24 of the protective tip 16. In theillustrated embodiment, the cap 32 includes a projection or extension orplug 34, which is shown as being elongated along a central axis of thecap 32. While the projection 34 is illustrated as having a solid,substantially cylindrical configuration with a substantially uniformouter diameter, it is also within the scope of the present disclosurefor the projection 34 to be differently configured (e.g.,non-cylindrical).

When the cap 32 has been mounted onto the protective tip 16, theprojection 34 is at least partially positioned within the protective tip16, as shown in FIG. 1. The projection 34 extends through the proximalopening 26 of the protective tip 16 (with the projection 34 holding theopening 26 in an at least partially open configuration) to sealinglycooperate with the protective tip 16 (or a component thereof) to providethe proximal and distal seals 28 and 30. Hence, it can be seen that theprojection 34 engages the protective tip 16 (or a component thereof) inat least three locations: at the proximal opening 26, at the proximalseal 28, and at the distal seal 30. It may be preferred for theprojection 34 to have a relatively small outer diameter at the portionwhich is positioned within the proximal opening 26 of the protective tip16 in order to prevent tip deformation or shape-setting during storageof the catheter assembly 10.

As noted above, the projection 34 sealingly engages the proximal anddistal seals 28 and 30 of the protective tip 16, thereby defining afluid- or water-tight seal at each of the internal seals 28 and 30. Theseals 28 and 30 are each configured to press against the outer surfaceof the projection 34, thereby forming a complete seal around an outerperimeter of the projection 34. To form such a fluid- or water-tightseal, each seal 28, 30 may be configured to define an opening oraperture with a cross-sectional shape that is comparable to thecross-sectional shape of the projection 34. For example, if theprojection 34 is substantially cylindrical (as in the illustratedembodiment), with a substantially circular cross-sectional shape, eachof the internal seals 28, 30 may substantially annular to define acentral circular opening or aperture. In other embodiments, if thecross-sectional shape of the projection 34 is non-circular, one or bothof the internal seals 28 and 30 may be configured to define openings orapertures which are similarly non-circularly configured to match thecross-sectional shape of the projection 34.

It may be preferred for the openings or apertures defined by theinternal seals 28 and 30 to be slightly smaller than the portion of theprojection 34 which is positioned within the opening or aperture whenthe cap 32 has been mounted onto the protective tip 16. Such aconfiguration may be preferred in order to promote a fluid- orwater-tight seal at each internal seal 28, 30, but it is also within thescope of the present disclosure for the openings or apertures defined bythe internal seals 28 and 30 to have a size and shape substantiallyidentical to that of the corresponding portion of the projection 34. Ifone or both of the internal seals 28 and 30 is configured to define anopening or aperture slightly smaller than the corresponding portion ofthe projection 34, it may be advantageous for that seal or those sealsto be formed of a deformable material to allow the seal to deformoutwardly to accommodate the larger cross-section of the projection 34.For example, in one embodiment, the internal seals 28 and 30 of theprotective tip 16 may be formed of an elastomeric material (e.g., anO-ring), which provides a fluid- or water-tight seal while beingdeformable. In other embodiments, different materials such as silicone;the polyether block amide material marketed as PEBAX® by Arkema S.A. ofColombes, France; thermoplastic polyurethanes; thermoplastic elastomers;thermoplastic polyolefins; and the like may be used. It is also withinthe scope of the present disclosure for the proximal seal 28 to beformed of a different material than the distal seal 30.

The proximal and distal internal seals 28 and 30 may be inner surfacesof the protective tip 16 or may be directly connected to the innersurface of the protective tip 16 or may be connected to the innersurface of the protective tip 16 via an intermediate member. Forexample, in the illustrated embodiment, the inner surface of theprotective tip 16 has a greater diameter at its distal end 22 than atits proximal end 24. In such an embodiment, it may be advantageous for agrommet or spacer or intermediate member 36 to be connected to the innersurface of the protective tip 16 (FIG. 1), with the grommet 36 definingan opening or aperture in which the distal seal 30 may be formed. Byproviding a grommet 36, the distal seal 30 may be positioned closer tothe central axis of the protective tip 16 without increasing the size ofthe distal seal 30. Alternatively, the grommet 36 itself (as a componentof the protective tip 16) may provide an internal seal or sealingsurface which sealingly engages the projection 34. The materialcomposition of the grommet 36 may vary without departing from the scopeof the present disclosure, but in one embodiment, the grommet 36 is agenerally annular member comprised of a generally rigid or semi-rigidmaterial having a relatively low water permeability. For example, thegrommet 36 may be made from a thermoplastic elastomer, such as anon-swellable polyolefin material or PEBAX® or the like.

With the cap 32 mounted upon the protective tip 16, the projection 34forms fluid- or water-tight seals at each internal seal 28, 30. By sucha configuration, a fluid reservoir or compartment 38 is defined betweenthe internal seals 28 and 30 of the protective tip 16 (FIG. 1). Anactivating or hydrating fluid may be contained within the fluidreservoir 38, which fluid is configured to interact with a coating (suchas, but not limited to, a hydrophilic coating) on the catheter 12 toprovide a lubricious surface to the catheter 12. The nature of theactivating fluid may vary depending on the nature of the coating on thecatheter 12 but, in one embodiment, the activating fluid is water. Thefluid reservoir 38 is at least partially filled with the activatingfluid during manufacture (e.g., between 2 and 5 ml of activating fluid)and remains within the fluid reservoir 38 during storage and until thecatheter assembly 10 is used, as described below. The fluid reservoir 38may be filled with the activating fluid by any suitable method, but inone embodiment, the activating fluid may be dispensed into the fluidreservoir 38 while only one of the seals 28 and 30 is in place. Inanother embodiment, activating fluid in a container (e.g., awater-soluble polymer pouch or container) may be inserted into the fluidreservoir 38, with the container being dissolved (in the case of awater-soluble container) or otherwise manipulated or processed torelease the activating fluid into the fluid reservoir 38 after the fluidreservoir 38 has been sealed. Other methods of dispensing activatingfluid into the fluid reservoir 38 may be employed without departing fromthe scope of the present disclosure.

As the fluid reservoir 38 is intended to house the activating fluidduring storage of the catheter assembly 10, it may be preferred for theprotective tip 16 (or at least the portion defining the fluid reservoir38) to be formed of a rigid or semi-rigid material having a relativelylow water permeability (e.g., polyethylene). Similarly, the projection34 of the cap 32 is intended to be at least partially positioned withinthe fluid reservoir 38 during storage of the catheter assembly 10, so itmay be advantageous for the cap 32 (or at least the projection 34) to beformed of a rigid or semi-rigid material having a relatively low waterpermeability. In one embodiment, the fluid reservoir 38 and theprojection 34 are formed of the same material, which may also be thesame material as is used to form the grommet 36, but in otherembodiments, the fluid reservoir 38, the projection 34, and the grommet36 may be formed of different materials.

In use, the catheter assembly 10 is provided to a user in theconfiguration shown in FIGS. 1 and 2. In one embodiment, the catheterassembly 10 may be enclosed within a sealed package or container (notillustrated) that must be opened by the user prior to use of thecatheter assembly 10. In other embodiments, the cap 32 and sleeve 14serve as a sealed package for the catheter 12. When the catheterassembly 10 has been removed from the package (if provided), the userpartially withdraws the cap 32 from the protective tip 16 (FIG. 3) so asto disengage the projection 34 from the distal internal seal 30. By sodisengaging the projection 34 from the distal internal seal 30, theactivating fluid is allowed to flow out of the fluid reservoir 38 andinto the sleeve 14 via the opening or aperture defined by the distalseal 30. It may be advantageous for the catheter assembly 10 to be heldvertically by the user, with the cap 32 and protective tip 16 pointingupwardly, to promote flow of the activating fluid out of the fluidreservoir 38 and into the sleeve 14. By only partially removing the cap32 from the protective tip 16, the projection 34 maintains the proximalinternal seal 28, thereby preventing the activating fluid from flowingout of the proximal opening 26 of the protective tip 16.

Alternatively, rather than only partially removing the cap 32 from theprotective tip 16, the user may completely remove the cap 32 from theprotective tip 16 to allow the activating fluid to flow from the fluidreservoir 38 into the sleeve 14. Although there is no proximal internalseal 28 maintained by the projection 34, the proximal opening 26 of theprotective tip 16 (in a closed configuration) may provide a fluid- orwater-tight seal to prevent the activating fluid from flowing out of thecatheter assembly 10.

The activating fluid contacts the hydrophilic coating of the catheter 12and interacts therewith to form a lubricious coating on the catheter 12.The sleeve 14 is preferably formed of a substantially transparent ortranslucent material to allow the user to visually confirm that theactivating fluid has covered the catheter 12 along the length of thecoating. It may also be advantageous for the sleeve 14 to be formed of aflexible material to allow the user to manipulate the catheter 12through the sleeve 14 to better apply the activating fluid to thecoating of the catheter 12. In one embodiment, the sleeve 14 is formedof a soft, hydrophilic material, such as a polyurethane film, althoughother thin, soft film materials (either vapor permeable or impermeable)may also be used without departing from the scope of the presentdisclosure.

After the catheter 12 has been treated with the activating fluid, thecap 32 may be fully removed from the protective tip 16 (if it has onlybeen partially withdrawn from the protective tip 16), as in FIG. 4,which moves the proximal opening 26 to its closed configuration.Thereafter, the lubricated catheter 12 may be advanced proximally intoand through the protective tip 16 to exit the protective tip 16 via theproximal opening 26. If the catheter assembly 10 is provided as aurinary catheter assembly, the proximal end 24 (including the proximalopening 26) of the protective tip 16 may be positioned within theurethra prior to advancing the catheter 12 out of the proximal opening26 of the protective tip 16. With the proximal end 24 of the protectivetip 16 in the urethra, the proximal end of the catheter 12 may beadvanced out of the proximal opening 26 of the protective tip 16 andthrough the urethra until the proximal end of the catheter 12 reachesthe bladder. Urine within the bladder flows into the open interior ofthe catheter 12 via one or more eyes or openings 40 of the catheter 12(FIG. 1), where it then flows through the catheter 12 and into thesleeve 14. More preferably, rather than allowing urine to flow into thesleeve 14, the distal end of the catheter 12 may include a funnel ordrainage device 42 (FIG. 5) that allows urine to drain out of thecatheter 12 and into a toilet or other waste receptacle. Thereafter, thecatheter 12 may be removed from the urethra, with the catheter assembly10 and urine being discarded after use.

FIG. 6 illustrates an alternative embodiment of a catheter assembly 10 aaccording to the present disclosure. The embodiment of FIG. 6 is similarto the catheter assembly 10 of FIGS. 1-5, with some differences in theconfigurations of the protective tip 16 a and the cap 32 a. In theembodiment of FIG. 6, the protective tip 16 a has a generally slimmerconfiguration than the protective tip 16 of FIGS. 1-5, with the distalend 22 a of the protective tip 16 a having a diameter that is largerthan that of the proximal end 24 a, but with the diameters being moresimilarly sized than in the embodiment of FIGS. 1-5. As in theembodiment of FIGS. 1-5, the distal seal 30 is provided at a grommet orspacer 36 a, with the proximal seal 28 being provided at an innersurface of the protective tip 16 a. However, it should be understoodthat the configurations of the internal seals 28 and 30 may vary, asdescribed above with regard to the embodiment of FIGS. 1-5.

As for the cap 32 a, it varies from the cap 32 of FIGS. 1-5 in that itsprojection 34 a defines a hollow portion or cavity 44 at a distalportion of the projection 34 a. By such a configuration, a proximal endor portion of the catheter 12 may be positioned within the hollowportion 44 of the projection 34 a during storage of the catheterassembly 10 a, prior to use. Such a configuration may be advantageous inthat a shorter sleeve 14 a may be employed, thereby decreasing thematerial cost of the catheter assembly 10 a and the storage spacerequired.

It will be seen that the catheter 12 has a smaller diameter than thedistal seal 30 in the embodiment of FIG. 6, such that removing the cap32 a results in a gap or separation between the catheter 12 and thedistal seal 30. This separation between the catheter 12 and the distalseal 30 allows activating fluid to flow out of the protective tip 16 aand into the sleeve 14 a when the cap 32 a (and, hence, the projection34 a) has been removed, thereby hydrating the portion of the catheter 12positioned within the sleeve 14 a.

FIG. 7 illustrates a variation of the embodiment of FIG. 6. The catheterassembly 10 b of FIG. 7 is substantially identical to the embodiment ofFIG. 6, except that it is provided with an additional or third orauxiliary seal or flow-limiting feature 46. In the illustratedembodiment, the third seal 46 is positioned distally of the distal seal30, at or adjacent to the distal end 22 a of the protective tip 16 a(i.e., outside and distally of the fluid reservoir 38). The third seal46 is configured to bear against the catheter 12, thereby forming eithera fluid- or water-tight seal therewith or providing a flow-limitingfeature. The third seal 46, when providing a fluid- or water-tight seal,helps to maintain the activating fluid within the fluid reservoir 38after the cap 32 a is removed from the protective tip 16 a by preventingthe activating fluid from flowing into the sleeve 14 a. By such aconfiguration, the activating fluid remains within the fluid reservoir38, such that the catheter 12 (and the coating thereof) comes intocontact with the activating fluid as the catheter 12 is advancedproximally through and out of the protective tip 16 a, rather than theactivating fluid contacting the coating within the sleeve 14 a. On theother hand, if the third seal 46 is configured to provide aflow-limiting feature, at least a portion of the third seal 46 may bespaced away or separated from the outer surface of the catheter 12 toallow a regulated or limited flow of activating fluid into the sleeve 14a when the cap 32 a is removed (as in the embodiment of FIG. 6).

The material composition of the third seal 46 may vary without departingfrom the scope of the present disclosure, but in one embodiment, thethird seal 46 is formed of the same material as one or both of the otherseals 28 and 30. In other embodiments, the third seal 46 may be formedof a different material than the other seals 28 and 30. Suitablematerials for the third seal 46 include, but are not limited to,elastomeric materials, silicone, PEBAX®, thermoplastic polyurethanes,thermoplastic elastomers, thermoplastic polyolefins, and other non-wovenfabric materials.

FIG. 8 illustrates yet another embodiment of a catheter assembly 10 caccording to the present disclosure. The catheter assembly 10 c of FIG.8 is comparable to the embodiment of FIGS. 1-5, except that it furtherincludes a sponge or absorbent member 48 associated with the protectivetip 16 to bear against the catheter 12. In the illustrated embodiment,the absorbent member 48 has a generally annular configuration and isassociated with the grommet 36, seated within a counterbore or pocket orcavity 50 at a distal side or end of the grommet 36 (i.e., outside anddistally of the fluid reservoir 38). By such a configuration, theabsorbent member 48 absorbs and retains a portion of the activatingfluid as it flows out of the fluid reservoir 38 and into the sleeve 14.As the catheter 12 is advanced proximally through the protective tip 16,it presses against the absorbent member 48, with the absorbent member 48applying some of the retained activating fluid to the surface (and,hence, the hydrophilic coating) of the catheter 12. This helps to ensurethat activated fluid is applied to the entirety of the coated portion ofthe catheter 12 as the catheter 12 is advanced out of the protective tip16. The material composition of the absorbent member 48 may vary withoutdeparting from the scope of the present disclosure but, in oneembodiment, the absorbent member 48 is formed of a sponge- or foam-likematerial, such as an open-cell sponge or foam material from foamedpolymers (e.g., polyethylene or polyurethane or polyvinyl chloride) orthe like.

FIG. 9 illustrates an alternative seal configuration. In the catheterassembly 10 d of FIG. 9, the projection 34 d of the cap 32 d is spacedaway from the protective tip 16 d at the proximal end 24 d of theprotective tip 16 d. A proximal fluid-tight seal is provided between theprotective tip 16 d and the cap 32 d by a fluid-tight film that issealed to the two components, such as by heat seals. In one embodiment,one or both of the heat seals may be a peelable or breakable, as will bedescribed in greater detail. In the embodiment of FIG. 9, threefluid-tight films 52 a, 52 b, and 52 c are provided, with a distal film52 c providing a distal seal, but it is within the scope of the presentdisclosure for the catheter assembly 10 d to include only one or twosuch films. For example, the fluid-tight film seal or seals may beconfigured to provide only a proximal seal, only a distal seal, or botha proximal seal and a distal seal for the fluid reservoir 38.

One of the illustrated films 52 a is provided within the protective tip16 d, at or adjacent to the proximal end 24 d of the protective tip 16d. The film 52 a extends from the inner surface of the protective tip 16d to the outer surface of the cap projection 34 d, being connected(e.g., by heat seals) to each component. Another illustrated film 52 bis positioned outside of the protective tip 16 d, at or adjacent to theproximal end 24 d of the protective tip 16 d. The second film 52 bextends from the outer surface of the protective tip 16 d to the outersurface of the cap 32 d (or a portion of the projection 34 d positionedoutside of the protective tip 16 d) and is connected (e.g., by heatseals) to each component. The third illustrated film 52 c is positionedwithin the sleeve 14 and is connected (e.g., by a heat seal) to thedistal end 22 d of the protective tip 16 d and/or the grommet 36 a ofthe protective tip 16 d, overlaying the opening through which thecatheter 12 may be advanced into the fluid reservoir 38. The third film52 c may also be connected (e.g., by a heat seal) to the distal end ofthe cap projection 34 d.

In use, the cap 32 d is moved proximally with respect to the protectivetip 16 d, thereby removing any slack in the films 52 a, 52 b, and 52 c.The slack in the proximal films 52 a and 52 b allows the projection 34 dto separate from the distal seal 30 while the proximal seals provided bythe films 52 a and 52 b remain intact. Preferably, the distal sealprovided by the film 52 c is broken before the proximal seals arebroken, such that the activating fluid flows out of the fluid reservoir38 (though the opening formerly sealed by the distal film 52 c) and intothe sleeve 14 to interact with the coating on the catheter 12. In oneembodiment, the distal film 52 c is connected to the distal end of thecap projection 34 d and configured to break or detach from theprotective tip 16 d or grommet 36 a upon sufficient proximal movement ofthe cap 32 d. In another embodiment, the distal film 52 c may beconfigured to be broken by proximal movement of the catheter 12 intocontact with the film 52 c. In yet another embodiment, the distal film52 c may be configured to dissolve over time (e.g., if the film 52 c isformed of a water-soluble material), which allows the activating fluidto be released into the sleeve 14 during storage of the catheterassembly 10 d for hydration of the catheter 12 over an extended periodof time. Alternatively, the distal film 52 c may be configured to onlyweaken over time, without dissolving, thereby preventing activatingfluid from entering the sleeve 14, while also making it easier for auser to break the distal seal.

Depending on the nature of the proximal films 52 a and 52 b, they mayeither break upon application of sufficient force or may be peeled offto separate them from one or both of the associated components of thecatheter assembly 10 d. Breaking/peeling the heat seals of the films 52a and 52 b allows for the cap 32 d to be fully removed and separatedfrom the protective tip 16 d. In one embodiment, the film 52 apositioned within the protective tip 16 d may be configured to dissolveor weaken over time (e.g., if the film 52 a is formed of a water-solublematerial), which makes it easier for a user to break the seal and removethe cap 32 d immediately prior to use.

FIGS. 10 and 11 illustrate catheter assemblies 10 e and 10 f havingalternatively configured sleeves 14 e and 14 f. The illustrated sleeves14 e and 14 f are configured to slow the rate at which activating fluidflows through the sleeve and to extend the time that the activatingfluid is in contact with all coated areas of the catheter 12. Either ofthe sleeves 14 e and 14 f may be used in combination with any of thecatheter assemblies described herein or with other catheter assembliesin which an activating fluid flows through a catheter-containing sleeve.

In the embodiment of FIG. 10, the sleeve 14 e is provided with aplurality of constrictions 54, but may have as few as one constriction54. The constrictions 54 effectively decrease the size of the gapbetween the sleeve 14 e and the catheter 12, thereby preventing theactivating fluid from quickly flowing through the sleeve 14 e. As theactivating fluid flows through the sleeve 14 e, it is funneled throughthe relatively small opening defined by each constriction 54, whichcauses the activating fluid to remain upstream of each constriction 54for a longer amount of time, in contact with the coating on the catheter12. The exact flow rate of the activating fluid through the sleeve 14 eand through the opening defined by each constriction 54 may be varied byadjusting the configuration of each constriction 54 (e.g., by increasingor decreasing the size of the opening defined by a constriction 54). Theconstrictions 54 may be formed by any suitable method, but in oneembodiment are formed by a heat sealing procedure that seals togetheropposing faces of the sleeve 14 e.

In the embodiment of FIG. 11, the sleeve 14 f is provided with aplurality of absorbent inserts 56, but may have as few as one absorbentinsert 56. The absorbent inserts 54 absorb a portion of the activatingfluid as it flows through the sleeve 14 f. As the catheter 12 isadvanced proximally out of the sleeve 14 f, it brushes against theabsorbent inserts 54, which transfer activating fluid to the coating ofthe catheter 12 (similar to the action of the absorbent member 48 ofFIG. 8). The sleeve 14 f may be squeezed at the absorbent inserts 56 totransfer additional amounts of activating fluid from the absorbentinserts 56 to the catheter 12. The configuration of the absorbentinserts 56 may vary, but it may be advantageous for them to besubstantially annular and formed from a sponge- or foam-like non-wovenfabric material, such as an open-cell sponge or foam material fromfoamed polymers (e.g., polyethylene or polyurethane or polyvinylchloride) or the like. The absorbent inserts 56 may be sealed or securedto the sleeve 14 f by any suitable means, which may vary according tothe material composition of the absorbent inserts 56 and the sleeve 14f.

It should be understood that the methods described herein are merelyexemplary, and that the steps described above may be carried out in adifferent order. Further, other steps may be included when using thedevices described herein. Additionally, one or more of the stepsdescribed herein in connection with the methods may be omitted ormodified without departing from the scope of the present disclosure.Similarly, the systems described herein are merely exemplary, and theymay be differently configured (e.g., by combining one or more componentsof one described embodiment with one or more components of anotherdescribed embodiment) without departing from the scope of the presentdisclosure.

Aspects of the present subject matter described above may be beneficialalone or in combination with one or more other aspects. Without limitingthe foregoing description, in accordance with one aspect of the subjectmatter herein, there is provided a catheter assembly, which includes asleeve with a catheter at least partially positioned therein. There is acoating on at least a part of the catheter which produces a low-frictionsurface on the catheter when treated with an activating fluid. Aprotective tip is connected to the sleeve and has proximal and distalinternal seals, with the proximal seal being positioned at a proximalend of the protective tip or between proximal and distal ends of theprotective tip. A cap includes a projection removably received withinthe protective tip for sealing engagement with the proximal and distalseals to define a fluid reservoir within the protective tip, with anactivating fluid contained within the fluid reservoir.

In accordance with another aspect which may be used or combined with thefirst aspect, the projection has a substantially uniform outer diameter.

In accordance with another aspect which may be used or combined with theany of the preceding aspects, at least one of the internal seals isformed of a deformable material.

In accordance with another aspect which may be used or combined with theany of the preceding aspects, a grommet is secured to an inner surfaceof the protective tip, with the grommet defining an opening in which thedistal internal seal is positioned.

In accordance with another aspect which may be used or combined with thefourth aspect, a distal side of the grommet defines a pocket, with agenerally annular absorbent member at least partially positioned withinthe pocket.

In accordance with another aspect which may be used or combined with anyof the preceding aspects, a distal portion of the projection defines acavity in which a proximal end of the catheter is positionable.

In accordance with another aspect which may be used or combined with thepreceding aspect, a third internal seal is positioned distally of thedistal internal seal, with the third internal seal being configured tobear against the catheter.

In accordance with another aspect which may be used or combined with thesixth aspect, a third internal seal is positioned distally of the distalinternal seal, with at least a portion of the third internal seal beingseparated from the catheter to provide a flow-limiting arrangement.

In accordance with another aspect, there is provided a catheterassembly, which includes a sleeve with a catheter at least partiallypositioned therein. There is a coating on at least a part of thecatheter which produces a low-friction surface on the catheter whentreated with an activating fluid. A protective tip is connected to thesleeve and defines a fluid reservoir, which contains an activatingfluid. A cap includes a projection removably received within theprotective tip. At least one fluid-tight film seal is positioned outsideof the protective tip and extends between an outer surface of theprotective tip and an outer surface of the cap or projection, within thefluid reservoir and extends between an internal surface of theprotective tip and an outer surface of the projection, or within thesleeve and connected to a distal end of the protective tip.

In accordance with another aspect which may be used or combined with thepreceding aspect, the fluid-tight film seal is peelable or breakable.

In accordance with another aspect which may be used or combined with anyof the preceding two aspects, the fluid-tight film seal is positionedoutside of the protective tip and extends between the outer surface ofthe protective tip and the outer surface of the cap or projection. Asecond fluid-tight film seal is positioned within the fluid reservoirand extends between the internal surface of the protective tip and theouter surface of the projection.

In accordance with another aspect which may be used or combined with anyof the ninth through tenth aspects, the fluid-tight film seal ispositioned outside of the protective tip and extends between the outersurface of the protective tip and the outer surface of the cap orprojection. A second fluid-tight film seal is positioned within thesleeve and is connected to the distal end of the protective tip.

In accordance with another aspect which may be used or combined with anyof the ninth through tenth aspects, the fluid-tight film seal ispositioned within the fluid reservoir and extends between the internalsurface of the protective tip and the outer surface of the projection. Asecond fluid-tight film seal is positioned within the sleeve and isconnected to the distal end of the protective tip.

In accordance with another aspect which may be used or combined with anyof the ninth through tenth aspects, the fluid-tight film seal ispositioned outside of the protective tip and extends between the outersurface of the protective tip and the outer surface of the cap orprojection. A second fluid-tight film seal is positioned within thefluid reservoir and extends between the internal surface of theprotective tip and the outer surface of the projection. A thirdfluid-tight film seal is positioned within the sleeve and is connectedto the distal end of the protective tip.

In accordance with another aspect which may be used or combined with anyof the ninth through tenth aspects, the fluid-tight film seal ispositioned within the sleeve, connected to a distal end of theprotective tip, and formed of a water-soluble material.

In accordance with another aspect which may be used or combined with anyof the preceding aspects, the sleeve includes a constriction configuredto reduce the space between the sleeve and the catheter.

In accordance with another aspect which may be used or combined with thepreceding aspect, the sleeve has opposing faces, with the constrictionbeing defined by a heat seal between the opposing faces of the sleeve.

In accordance with another aspect which may be used or combined with anyof the preceding two aspects, the sleeve includes a second constrictionconfigured to reduce the space between the sleeve and the catheter.

In accordance with another aspect which may be used or combined with anyof the first through fifteenth aspects, an absorbent insert ispositioned within the sleeve.

In accordance with another aspect which may be used or combined with thepreceding aspect, a second absorbent insert is positioned within thesleeve.

It will be understood that the embodiments described above areillustrative of some of the applications of the principles of thepresent subject matter. Numerous modifications may be made by thoseskilled in the art without departing from the spirit and scope of theclaimed subject matter, including those combinations of features thatare individually disclosed or claimed herein. For these reasons, thescope hereof is not limited to the above description but is as set forthin the following claims, and it is understood that claims may bedirected to the features hereof, including as combinations of featuresthat are individually disclosed or claimed herein.

1. A catheter assembly, comprising: a sleeve; a catheter at leastpartially positioned within the sleeve and having a coating on at leasta part of its length which produces a low-friction surface on thecatheter when treated with an activating fluid; a protective tipconnected to the sleeve and having proximal and distal internal seals,with the proximal seal positioned at a proximal end of the protectivetip or between proximal and distal ends of the protective tip; a capincluding a projection removably received within the protective tip forsealing engagement with the proximal and distal seals to define a fluidreservoir within the protective tip; and an activating fluid containedwithin the fluid reservoir.
 2. The catheter assembly of claim 1, whereinthe projection has a substantially uniform outer diameter.
 3. Thecatheter assembly of claim 1, wherein at least one of the internal sealsis formed of a deformable material.
 4. The catheter assembly of claim 1,further comprising a grommet secured to an inner surface of theprotective tip, wherein the grommet defines an opening in which thedistal internal seal is positioned.
 5. The catheter assembly of claim 4,wherein a distal side of the grommet defines a pocket, and a generallyannular absorbent member is at least partially positioned within thepocket.
 6. The catheter assembly of claim 1, wherein a distal portion ofthe projection defines a cavity in which a proximal end of the catheteris positionable.
 7. The catheter assembly of claim 6, further comprisinga third internal seal positioned distally of the distal internal seal,wherein the third internal seal is configured to bear against thecatheter.
 8. The catheter assembly of claim 6, further comprising athird internal seal positioned distally of the distal internal seal,wherein at least a portion of the third internal seal is separated fromthe catheter to provide a flow-limiting arrangement.
 9. A catheterassembly, comprising: a sleeve; a catheter at least partially positionedwithin the sleeve and having a coating on at least a part of its lengthwhich produces a low-friction surface on the catheter when treated withan activating fluid; a protective tip connected to the sleeve anddefining a fluid reservoir; a cap having a projection removably receivedwithin the protective tip; an activating fluid contained within thefluid reservoir; and at least one fluid-tight film seal, wherein the atleast one fluid-tight film seal is positioned outside of the protectivetip and extends between an outer surface of the protective tip and anouter surface of the cap or projection; positioned within the fluidreservoir and extends between an internal surface of the protective tipand an outer surface of the projection; or positioned within the sleeveand connected to a distal end of the protective tip.
 10. The catheterassembly of claim 9, wherein the at least one fluid-tight film seal ispeelable or breakable.
 11. The catheter assembly of claim 9, wherein theat least one fluid-tight film seal is positioned outside of theprotective tip and extends between the outer surface of the protectivetip and the outer surface of the cap or projection, and furthercomprising a second fluid-tight film seal positioned within the fluidreservoir and extending between the internal surface of the protectivetip and the outer surface of the projection.
 12. The catheter assemblyof claim 9, wherein the at least one fluid-tight film seal is positionedoutside of the protective tip and extends between the outer surface ofthe protective tip and the outer surface of the cap or projection, andfurther comprising a second fluid-tight film seal positioned within thesleeve and connected to the distal end of the protective tip.
 13. Thecatheter assembly of claim 9, wherein the at least one fluid-tight filmseal is positioned within the fluid reservoir and extends between theinternal surface of the protective tip and the outer surface of theprojection, and further comprising a second fluid-tight film sealpositioned within the sleeve and connected to the distal end of theprotective tip.
 14. The catheter assembly of claim 9, wherein the atleast one fluid-tight film seal is positioned outside of the protectivetip and extends between the outer surface of the protective tip and theouter surface of the cap or projection, and further comprising a secondfluid-tight film seal positioned within the fluid reservoir andextending between the internal surface of the protective tip and theouter surface of the projection, and a third fluid-tight film sealpositioned within the sleeve and connected to the distal end of theprotective tip.
 15. The catheter assembly of claim 9, wherein the atleast one fluid-tight film seal is positioned within the sleeve,connected to a distal end of the protective tip, and formed of awater-soluble material.
 16. The catheter assembly of claim 1, whereinthe sleeve includes a constriction configured to reduce the spacebetween the sleeve and the catheter.
 17. The catheter assembly of claim16, wherein the sleeve comprises opposing faces, and the constriction isdefined by a heat seal between the opposing faces of the sleeve.
 18. Thecatheter assembly of claim 16, wherein the sleeve includes a secondconstriction configured to reduce the space between the sleeve and thecatheter.
 19. The catheter assembly of claim 1, further comprising anabsorbent insert positioned within the sleeve.
 20. The catheter assemblyof claim 19, further comprising a second absorbent insert positionedwithin the sleeve.